FDA.reportPublic FDA data

NDC 0378-0711-10 - Methyldopa and Hydrochlorothiazide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0378-0711
Requested NDC
0378-0711-10
Package NDCs from labels
0378-0711-01, 0378-0711-10
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2020-04-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methyldopa and Hydrochlorothiazide - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2020-04-13HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0711-01EA - Each0378-07116ee8eeee-ee84-449c-bbf5-8d75ecaeb28112012-07-24
0378-0711-10EA - Each0378-07111707a9cc-aa79-447b-8d9f-7b128b10e3f912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THMETHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
METHYLDOPAACTIVE INGREDIENT56LH93261YMETHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THMETHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
METHYLDOPA ANHYDROUSACTIVE MOIETYM4R0H12F6MMETHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMETHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMETHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMETHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6
TRIACETININACTIVE INGREDIENTXHX3C3X673METHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]6

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 160 · 3,181 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack53221419-204c-40a2-9ec3-8e4b994dd39d2026-08-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEA-S Medication Solutions12ba7eba-1874-41b6-aff5-7baba8b999842026-08-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack154cb1d2-9fb2-4c8d-90de-6a8062a8d1ba2026-08-19Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEANI Pharmaceuticals, Inc.a26bcf78-6515-4e9f-b2dc-4aaa8ec1a82c2026-08-12Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
bisoprolol fumarate and hydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.27d52b23-e3e2-4339-b00e-cd0fec43ffbb2026-08-11Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSREMEDYREPACK INC.3bea11a3-eb07-46b2-9b91-f8a48a2f3b7e2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.